510(k) K971689

IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT by Euro-Diagnostica AB — Product Code MOB

K971689 is an FDA 510(k) premarket notification submitted by Euro-Diagnostica AB for the device "IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT". The FDA issued a decision of Substantially Equivalent on October 29, 1997. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Euro-Diagnostica AB has at least 5 other 510(k) clearances on record.